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Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial

NCT00414726 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-10-20

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom onset), to standard medical treatment.

Conditions

Interventions

DRUG

NBO (Normobaric Oxygen)

High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.

DRUG

Room Air

Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Aneesh B Singhal, MD · Massachusetts General and Brigham & Women's Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00414726 on ClinicalTrials.gov